Caffeine compositions and methods of use

Abstract

A pharmaceutical composition formulated for intranasal administration comprising a natural caffeine extract, a pharmaceutically acceptable excipient, a pharmaceutically acceptable aqueous carrier; and, optionally, additional caffeine, or a pharmaceutically acceptable salt, solvate, derivative or metabolite thereof. Methods of preparation and methods of use are also described.

1 - 30 . (canceled) 
     
     
         31 . A method of treating or preventing a craving for coffee in an individual, or treating or preventing caffeine withdrawal or a symptom of caffeine withdrawal in an individual, comprising administering to the individual via intranasal delivery an aqueous pharmaceutical composition comprising a natural caffeine extract and at least one pharmaceutically acceptable excipient. 
     
     
         32 . The method according to  claim 31 , wherein the natural caffeine extract is coffee extract. 
     
     
         33 . The method according to  claim 31 , wherein the method maintains a nil-by-mouth status. 
     
     
         34 . The method according to  claim 31 , wherein the method is carried out prior to a medical procedure. 
     
     
         35 . The method according to  claim 31 , wherein the composition further comprises caffeine or a pharmaceutically acceptable salt, solvate, derivative or metabolite thereof. 
     
     
         36 . The method according to  claim 35 , wherein the composition comprises total caffeine in an amount of about 0.5 to 2.2% w/v. 
     
     
         37 . The method according to  claim 31 , wherein the composition is delivered by a nasal spray dispenser. 
     
     
         38 . The method according to  claim 37 , wherein the dispenser is a metered dose device. 
     
     
         39 . The method according to  claim 38 , wherein the dispenser is configured to dispense a total volume of the composition of 0.05-0.2 mL per actuation. 
     
     
         40 . The method according to  claim 39 , wherein the dispenser is configured to dispense a total volume of the composition of approximately 0.1 mL per actuation. 
     
     
         41 . The method according to  claim 40 , wherein the dispenser delivers approximately 2 mg of caffeine per 0.1 mL actuation. 
     
     
         42 . The method according to  claim 31 , wherein the caffeine extract is in an amount in the range of from 10-30% v/v of the composition. 
     
     
         43 . The method according to  claim 31 , wherein the at least one pharmaceutically acceptable excipient is selected from preservatives, humectants, tonicity agents, buffering agents, flavourings and stabilizers. 
     
     
         44 . The method according to  claim 31 , wherein the at least one pharmaceutically acceptable excipient is a preservative. 
     
     
         45 . The method according to  claim 44 , wherein the preservative is potassium sorbate. 
     
     
         46 . The method according to  claim 31 , wherein the pharmaceutically acceptable aqueous carrier is phosphate buffered saline. 
     
     
         47 . The method according to  claim 31 , wherein the pharmaceutical composition comprises, consists or consists essentially of:
 coffee extract: 8-30% v/v;   additional caffeine: 0.5-2% w/v;   at least one pharmaceutically acceptable excipient; and   saline: 65-90% v/v.   
     
     
         48 . The method according to  claim 31 , wherein the pharmaceutical composition comprises, consists or consists essentially of:
 coffee extract: 10-30% v/v;   additional caffeine: 0.5-2% w/v;   potassium sorbate: 0.05-0.2% w/v;   glycerol: 0.5-2% v/v;   hypromellose: 0.01-1% w/v; and   phosphate buffered saline to 100%.   
     
     
         49 . The method according to  claim 31 , wherein the natural caffeine extract is an aqueous extract of roasted coffee beans. 
     
     
         50 . The method according to  claim 31 , wherein the natural caffeine extract comprises caffeine in an amount in the range of from 2 mg/mL to 10 mg/mL of the extract.